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Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke

RecruitingNAAges 19 Years - anyAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

Lipid-lowering therapy constitutes a cornerstone of secondary prevention in ischemic stroke; however, current stroke guidelines remain deficient in providing optimal target low-density lipoprotein (LDL)-cholesterol levels tailored to the stroke subtypes. Most clinical trials on LDL-cholesterol management have not differentiated between stroke subtypes or have primarily focused on large artery atherosclerosis (LAA) stroke, leaving a gap in evidence for managing LDL-cholesterol in other stroke subtypes, e.g., small vessel occlusion (SVO) stroke. While hypertension is the leading risk factor for SVO strokes, the link between elevated LDL-cholesterol and SVO stroke is also recognized. Establishing optimal LDL-cholesterol targets for SVO stroke would significantly enhance secondary prevention strategies and improve patient outcome. Thus, the investigators aim to compare intensive versus stand

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 19 years or older 2. Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT) 3. Patients with a history of symptomatic ischemic stroke caused by the lesion described in 2), occurring within 180 days prior to enrollment 4. Patients or guardians who agree to the study protocol and sign with informed consent Exclusion Criteria: 1. Extracranial or intracranial large artery stenosis ≥50% 2. History of atherosclerotic ischemic stroke or transient ischemic attack 3. Documented coronary artery disease 4. Documented peripheral artery disease or aortic atherosclerotic disease 5. Diabetes with one or more of the following: duration ≥10 years; ≥2 major risk factors (men ≥45 years, women ≥55 years; family history of premature atherosclerotic cardiovascular disease; hypertension; current smoking; or HDL cholesterol \<40 mg/dL); or known evidence of target organ damage (albuminuria, estimated glomerular filtration rate \<60 mL/min per 1.73 m², retinopathy, neuropathy, or left ventricular hypertrophy) 6. Baseline LDL cholesterol \<70 mg/dL in the absence of lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors, etc.) 7. Patients contraindicated for statin use (e.g., active liver disease, serum transaminase levels elevated more than three times the normal limit, muscle disorders, hypersensitivity to statins, or taking medications contraindicated for use with statins) 8. Women who are pregnant, breastfeeding, or intending to become pregnant during the study period 9. Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion
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What it tests

  • Statins and/or Ezetimibe
  • PCSK9 inhibitor
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Where

46 sites
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Pusan National University Hospital
Busan, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Samsung Changwon Hospital
Changwon, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Kangwon National University Hospital
Chuncheon, South Korea

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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